Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria
Charlie Blackie-Kelly | September 26, 2025 | News story | Research and Development | Dupixent, Regeneron, Sanofi, urticaria
Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Dupixent (dupilumab) in chronic spontaneous urticaria (CSU). The committee has recommended approval of the treatment for adults and adolescents aged 12 years and older.
CSU is an inflammatory skin disease characterised by the sudden onset of hives and itching. It is partly driven by type 2 inflammation. Current therapies typically target histamine-1 (H1) receptors to control symptoms, but the condition remains uncontrolled despite H1 antihistamine (H1AH) treatments.
Dupixent (also known as dupilumab) is a fully human monoclonal antibody (mAb) that inhibits signalling in the interleukin-4 (IL4) and -13 (IL13) pathways. Jointly developed by Sanofi and Regeneron under a collaborative agreement, it has so far been used to treat a variety of chronic diseases caused by type 2 inflammation.
The CHMP’s recommendation applies to patients with moderate to severe disease who have had an inadequate response to H1AH and who are naïve to anti-immunoglobulin E (IgE) therapy. It follows results from two phase 3 trials in the LIBERTY-CUPID programme (studies A and C), which demonstrated a statistically significant reduction in itch and hives at 24 weeks versus placebo.
A third study (study B) assessed Dupixent’s safety in a different patient population. Adverse events were more frequent in the treatment group compared with placebo, although findings were consistent with the established safety profile.
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